3. 21 CFR 50 - ANS ✔Protection of Human Subjects/Informed Consent
4. 21 CFR 56 - ANS ✔IRB
5. 21 CFR 812 - ANS ✔IDE
6. 3 regulatory agency sponsors of ICH - ANS ✔European Union,
Japan, United States
7. 45 CFR - ANS ✔The Common Rule
8. 45 CFR Part B - ANS ✔Pregnant Women and Foetuses
9. 45 CFR Part C - ANS ✔Prisoners
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10. 45 CFR Part D - ANS ✔Children
11. 45 CFR Part E - ANS ✔IRBs
12. According to GCP guidelines, does the term vulnerable
subject also include employees under direct supervision of
clinical investigator? - ANS ✔Yes
13. According to ICH guidelines, how many members should
an IRB have? - ANS ✔at least 5
14. According to ICH guidelines, IRB must retain records for... -
ANS ✔3 years
15. Act - ANS ✔The Food, Drug and Cosmetic Act, as amended.
16. Adverse Drug Reaction (ADR) - ANS ✔All noxious and
unintended responses to a medicinal product related to any dose.
(ICH GCP E6 1.1)
17. Adverse Event (AE) - ANS ✔Any untoward medical
occurrence in a patient or clinical investigation subject administered
a pharmaceutical product and which does not necessarily have a
causal relationship with this treatment. (ICH GCP E6 1.2)
18. Applicable Regulatory Requirements - ANS ✔Any laws and
regulations addressing the conduct of clinical trials of investigational
products (ICH GCP E6 1.4)
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19. Are devices intended solely for veterinary use exempt
form IDE regulations? - ANS ✔Yes
20. Assent - ANS ✔A child's affirmative agreement to participate
in a clinical investigation. Mere failure to object may not, absent
affirmative agreement, be construed as assent. (21 CFR, sec. 50.3)
21. Audit - ANS ✔A systematic and independent examination of
trial related activities and documents to determine whether the
evaluated trial related activities were conducted, and the data were
recorded, analyzed and accurately reported according to the
protocol, sponsors SOPs, GCP and the applicable regulatory
requirements. (ICH GCP E6 1.6)
22. Audit Certificate - ANS ✔A declaration of the confirmation by
the auditor that an audit has taken place. (ICH GCP E6 1.7)
23. Audit Report - ANS ✔A written evaluation by the sponsor's
auditor of the results of the audit. (ICH GCP E6 1.8)
24. Audit Trail - ANS ✔Documentation that allow reconstruction
of the course of events. (ICH GCP E6 1.9)
25. Belmont Report - ANS ✔1979
26. Biometrics - ANS ✔A method of verifying an individual's
identity based on measurement of the individual's physical features
or repeatable actions where those features and or actions are both
unique to that individual and measurable. (21 CFR, Sec. 11.3)
SoCRA Certification Exam
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